HCRN-GU16-260
Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
Status: Closed to Accrual
This study is a prospective phase II trial of nivolumab in 120 treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) and 40 treatment naïve patients with non-clear cell renal cell carcinoma (nccRCC). The primary objective is to determine the progression-free survival (PFS) rate at one year of nivolumab in patients with treatment-naïve ccRCC based on tumor PD-L1 expression.
- Condition: Advanced renal cell carcinoma
- Intervention:
- Drug: Nivolumab
- Drug: Ipilimumab
- Phase: Phase II
For full description, see https://clinicaltrials.gov/study/NCT03117309.
Read a news release about this trial.
Abstracts/Posters/Presentations:
- MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, J Hawley, JA Sosman, RS Alter, ER Plimack, MC Ornstein, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B). Presented as poster discussion at the 2021 American Society of Clinical Oncology Annual Meeting. See abstract.
- MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, CG Drake, JA Sosman, RS Alter, ER Plimack, BI Rini, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260). Presented as an oral abstract at the 2020 American Society of Clinical Oncology Annual Meeting. See abstract.
Study Contact: studies@hoosiercancer.org; (317) 921-2050.
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